Monitoring System for Pressure Injury

This application is a continuation of U.S. patent application Ser. No. 17/557,554, filed on Dec. 21, 2021, entitled “MONITORING SYSTEM FOR PRESSURE INJURY,” which claims priority to U.S. Provisional Patent Application No. 63/131,851, filed on Dec. 30, 2020, entitled “MONITORING SYSTEM FOR PRESSURE INJURY,” the disclosure to each is hereby incorporated herein by reference in its entirety.

The present disclosure generally relates to a monitoring system, and more particularly to a monitoring system for a pressure injury.

According to one aspect of the present disclosure, a monitoring system for tracking pressure related injury risk includes a support apparatus with a controller and communication circuitry configured to communicate via a communication network. A control unit is configured to communicate with at least one of a remote server and the support apparatus via the communication network. The control unit is configured to determine at least one of a risk status and a risk score for developing a pressure injury in response to communication from the at least one of the remote server and the support apparatus, determine at least one contributing risk factor for developing the pressure injury, and generate a notification configured to be communicated to a user interface assembly.

According to another aspect of the present disclosure, a monitoring system for tracking pressure related injury risk includes a support apparatus with a controller. The controller is configured to communicate data relating to the support apparatus. Communication circuitry is operably coupled to the support apparatus. The communication circuitry is configured to communicate the data via a communication network. A control unit is configured to communicate with the support apparatus and a user interface assembly via the communication network. The control unit is configured to determine at least one of a risk status and a risk score for developing a pressure injury, determine an area of increased risk for developing the pressure injury; and generate a notification including a graphical representation of a person that is displayed via the user interface assembly.

According to yet another aspect of the present disclosure, a monitoring system for tracking pressure related injury risk includes a treatment device with a controller. The controller is configured to communicate data relating to the treatment device. Communication circuitry is operably coupled to the treatment device. The communication circuitry is configured to communicate the data via a communication network. A control unit that communicates with at least one of the treatment device and a user interface assembly via the communication network. The control unit is configured to determine at least one of a risk status and a risk score for developing a pressure injury and generate a first notification configured to be communicated to the user interface assembly. The first notification includes a selectable feature. The selectable feature corresponds to at least one of a risk status indicator, a risk score indicator, a risk assessment, a risk area, and a prevention treatment order. The control unit is configured to generate a second notification in response to a selection of at least one of the selectable features. The control unit is configured to communicate the second notification to the user interface assembly.

These and other features, advantages, and objects of the present disclosure will be further understood and appreciated by those skilled in the art by reference to the following specification, claims, and appended drawings.

The present illustrated embodiments reside primarily in combinations of method steps and apparatus components related to a monitoring system for a pressure injury. Accordingly, the apparatus components and method steps have been represented, where appropriate, by conventional symbols in the drawings, showing only those specific details that are pertinent to understanding the embodiments of the present disclosure so as not to obscure the disclosure with details that will be readily apparent to those of ordinary skill in the art having the benefit of the description herein. Further, like numerals in the description and drawings represent like elements.

1 FIG. For purposes of description herein, the terms “upper,” “lower,” “right,” “left,” “rear,” “front,” “vertical,” “horizontal,” and derivatives thereof, shall relate to the disclosure as oriented in. Unless stated otherwise, the term “front” shall refer to a surface closest to an intended viewer, and the term “rear” shall refer to a surface furthest from the intended viewer. However, it is to be understood that the disclosure may assume various alternative orientations, except where expressly specified to the contrary. It is also to be understood that the specific structures and processes illustrated in the attached drawings, and described in the following specification are simply exemplary embodiments of the inventive concepts defined in the appended claims. Hence, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered as limiting, unless the claims expressly state otherwise.

The terms “including,” “comprises,” “comprising,” or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. An element preceded by “comprises a . . . ” does not, without more constraints, preclude the existence of additional identical elements in the process, method, article, or apparatus that comprises the element.

1 18 FIGS.- 10 12 14 14 12 16 12 18 20 22 12 18 20 22 12 20 24 26 Referring to, reference numeralgenerally designates a monitoring system for tracking pressure injury risk that includes at least one support apparatushaving a controller. The controlleris configured to communicate use data or information relating to the support apparatus. Communication circuitryis operably coupled to the support apparatusand is configured to communicate via a communication network. A control unitis configured to communicate with at least one of a remote serverand the support apparatusvia the communication network. The control unitis configured to determine at least one of a risk status and a risk score for developing a pressure injury in response to communication with at least one of the remote serverand the support apparatus. The control unitis configured to generate a notificationconfigured to be communicated to a user interface assembly.

1 3 FIGS.- 10 30 40 40 40 40 40 40 42 44 40 10 40 Referring to, the monitoring systemis configured to retrieve information from a variety of information sourcesto determine the risk status, the risk score, or both of a patient during the stay at a medical facility. This information may also be referred to as the use information and may include data about the use of various devices, time of use, type of use, sensed information about the patient, etc. The patient at the medical facilitymay be transported between several areas or units while at the medical facility. For example, the patient may be transferred between different departments or units on different floorsA-D within the medical facilitydepending on a treatment or procedure to be received. The patient may be transported between a room environment, a surgical suite, imaging environments, etc. When the patient is transported between the different areas and rooms of the medical facility, different caregivers or caregiving teams may care for the patient. The monitoring systemis configured to retrieve information from the various caregiving teams and units to monitor the risk of pressure injury development during the stay at the medical facility.

30 30 56 22 46 48 50 52 54 56 58 40 The various information sourcesmay provide information that affects whether the patient is more likely to develop a pressure injury and a treatment process provided by the caregiver. The information sourcesmay include, but are not limited to, treatment devices, the remote server, electronic medical records (EMR), facility risk protocols, a remote device, a facility connected device, a local server, the treatment devices, a caregiver interaction system, other systems of the medical facility, or a combination thereof.

1 3 FIGS.- 40 Referring still to, the patient may arrive at the medical facilityfor one or more surgical procedures and be included in a perioperative environment, which includes a preoperative phase, an intraoperative phase, and a postoperative phase based on the timing relative to a surgical procedure. In the preoperative phase, a caregiver generally conducts a pressure injury assessment to determine a risk of the patient developing a pressure injury.

56 A pressure injury is localized damage to the skin and underlying soft tissue. Generally, the pressure injury is developed over a bony prominence and may be related to the use of the medical or treatment device. Pressure injuries develop as a result of intense pressure, prolonged pressure, pressure in combination with shear, or a combination thereof. There are stages of severity of pressure injuries. These stages include stage one of non-blanchable erythema of intact skin, stage two of partial-thickness skin loss with exposed dermis, stage three of full-thickness skin loss, stage four of full-thickness skin and tissue loss, and unstageable pressure injury of obscured full-thickness skin and tissue loss. For example, the pressure injury may present as intact skin, an open ulcer, purple discoloration, or blistering of the skin within 48 to 72 hours after a surgical procedure. A variety of factors contribute to the tolerance of the soft tissue for pressure and shear, including, microclimate, nutrition, perfusion, comorbidities, and the condition of the soft tissue.

56 40 40 The intraoperative pressure injury may be a deep tissue injury that is discovered post-surgery within a subsequent care environment (e.g., a medical/surgical unit, an intensive care unit, other post-operative care, a stepdown unit, at home, etc.). Additionally or alternatively, the medical or treatment deviceused by the caregiver may cause a pressure injury, which is generally referred to as a medical device related pressure injury (e.g., a type of pressure injury). A medical device related pressure injury generally results from the use of devices designed and applied for diagnostic or therapeutic purposes. The pressure injury may conform to the pattern of shape of the device. A subset of the medical device related pressure injury is a mucosal membrane pressure injury, which is found on mucous membranes with a history of medical device use at the location of the pressure injury (e.g., a nose, a mouth, etc.) Intraoperative pressure injuries and medical device related pressure injuries are generally obtained while the patient is at the medical facilityand may be discovered while in another unit of the medical facilityor in the subsequent care environment.

40 Upon the patient arriving at the medical facility, the caregiver may conduct an initial pressure injury assessment that provides an initial risk status or an initial risk score associated with the patient that corresponds with the likelihood of the patient developing a pressure injury. To conduct the initial assessment, the caregiver may utilize one or more risk assessment tools, such as the Braden scale, the Norton scale, the Waterlow scale, the Scott Triggers, or a combination thereof. The Braden scale generally rates sensory perception, moisture, activity, mobility, nutrition, and friction and shear of the patient on a scale between two numerical values (e.g., between one and four or between one and three for friction and shear). The score for each category is added to create a total score where a higher score corresponds to a lower risk of developing a pressure injury. The Norton scale assesses five subcategories, including physical condition, mental condition, activity, mobility, and incontinence on a scale between one and four. A higher score corresponds to a lower risk of the patient developing a pressure injury.

The Waterlow scale uses varying numerical values to assess body mass index (BMI), skin type/visual risk areas, sex, incontinence, and mobility. The Waterlow scale also includes special risk categories, such as malnutrition assessments, neurological deficits, medications, and major surgeries or traumas. The score for each category is added together to produce the risk score, where a higher value corresponds with a higher risk of the patient developing a pressure injury.

12 The Scott Triggers are a set of evidence-based factors identified as predictors of high risk for pressure injury development. The assessment reviews four “triggers” and whether each trigger meets a specified qualification. The triggers and associated qualifications include whether the patient is over age 62, has serum albumin levels of less than 3.5 g/L or a BMI less than 19 or greater than 40, has a physical status classification (ASA) score greater than 3, and has an estimated surgery time from entering to exiting the operating room of over 180 minutes. Two or more “yes” answers to the triggers and the surgical patient is considered at high risk of developing a pressure injury. Generally, whether using the Braden scale, the Norton scale, the Waterlow scale, or the Scott Triggers, significant factors in determining the risk score or the likelihood that a patient develops the pressure injury include the length of a surgical procedure and the related time on the support apparatusduring the surgical procedure. These two factors generally result in unrelieved pressure when the patient is under the physiological effects of anesthetic gas and medicines, which contributes to the development of the pressure injury.

40 12 56 40 The risk of the patient developing a pressure injury is cumulative during the time the patient is at the medical facility. Accordingly, time spent on the support apparatusor using other treatment devicesthroughout the treatment process all contribute to the risk of developing a pressure injury. For example, if the patient is at the medical facilityfor a surgical procedure, time in the preoperative phase, the intraoperative phase, and the postoperative phase before being discharged to the subsequent care all contribute to the risk of developing a pressure injury.

1 3 FIGS.- 60 50 60 50 52 40 50 52 54 40 50 52 60 54 60 22 60 60 60 Referring still to, upon intake of the patient, a new patient profileis created, which may be entered via a computerized software program or an application on the remote deviceutilized by caregivers. The patient profilemay be created through the remote device(e.g., a phone, a tablet, a laptop, a wearable device, etc.) or the facility connected device(e.g., a desktop or other computer within the medical facility, such as at a central nurse call station). The remote deviceand the facility connected deviceare each in communication with the local serverwithin the medical facility. Accordingly, using either the remote deviceor the facility connected device, the patient profilemay be created and communicated to and at least partially stored in the local server. The patient profilemay also be at least partially stored within the remote serverwithout departing from the teachings herein. Each caregiver associated with the patient is added or granted access to the patient profileto review, add, or remove information in the patient profile. Additional users may be manually added to the patient profile, and the users may be searched within the software or application by name, role, unit, or team assignments.

50 52 54 54 58 40 58 46 Both the remote deviceand the facility connected devicemay include an application or software program associated with and configured to interact with software on the local server. The software of the local servermay include the caregiver interaction systemto provide a communication platform for connecting each caregiver associated with the patient. For example, the caregiver associated with the patient in the preoperative phase, a surgical team associated with the patient in the intraoperative phase, and a caregiver associated with the patient in the postoperative phase may all communicate about the status of the patient and the related treatment through the software on the various devices and servers. Further, the software allows the caregivers to maintain and update the history of the patient across different shifts of caregivers and treatments within the medical facility. The software for the caregiver interaction systemmay be advantageous for communicating information that may not usually be stored within medical or health records (e.g., the EMR) of the patient.

40 50 52 54 60 40 40 The interconnectedness of the devices and servers may be advantageous for reporting a variety of information regarding the patient during the perioperative stay or treatment process of the patient at the medical facility. Accordingly, the remote device, the facility connected device(such as a room computer or a computer at a nurse station), and the local servereach include the software for accessing the patient profile, creating an interconnected network of caregivers associated with the patient. The interconnected network extends through the medical facilityand may extend beyond the medical facilityto other caregivers at other facilities associated with the patient.

1 3 FIGS.- 4 FIG. 3 FIG. 56 40 42 56 12 62 64 66 62 40 Referring still to, as well as, a variety of treatment devicesmay be utilized in the perioperative environment and/or for providing treatment to the patient at the medical facility. For example, as illustrated in, the room environmentmay include multiple treatment devices, such as the support apparatusconfigured as a medical bed, a vital signs monitor, and an oxygen therapy device. Based on the treatment or surgical procedure, the patient may be positioned on the medical bedfor a period of time during the stay at the medical facility, which may contribute to the development of a pressure injury.

64 68 68 70 72 64 56 74 66 56 5 FIG. 2 Additionally or alternatively, various vital signs of the patient may be monitored through the vital signs monitor. For example, a pulse oximetry sensor() may be utilized to determine a blood oxygen level or SpOof the patient. Generally, the pulse oximetry sensoris configured as a finger clasp worn by the patient. Additional devices worn or otherwise utilized to obtain vital signs data include, for example, a blood pressure cuffand an electrocardiogram. Additional monitors associated with the vital signs monitormay include, for example, electroencephalographs, heart rate monitors, respiration rate monitors, temperature monitors, blood pressure monitors, and the like. Further, additional treatment devicesmay include an incontinence sensor, a mobility sensor, a nasal cannula(e.g., oxygen tubing) associated with the oxygen therapy device, oxygen tubing for ears, a Foley catheter, a cast, a splint, a cervical collar, a continuous positive airway pressure (CPAP) mask, a bilevel positive airway pressure (BiPAP) mask, an endotracheal tube, a feeding tube, a halo brace, and a tracheostomy neck plate. Each of these treatment devicesmay be utilized for a period of time, which may contribute to a pressure injury depending on the patient, the treatment, and the risk score of the patient.

4 FIG. 56 44 64 44 12 80 80 80 56 40 As best illustrated in, if the patient undergoes one or more surgical procedures additional or alternative treatment devicesmay be utilized in the surgical suite. For example, the vital signs monitormay be used in the surgical suiteto monitor the vital signs of the patient during the surgical procedures. Additionally, the patient is generally positioned on the support apparatus, which is configured as a surgical tablefor use during the one or more surgical procedures. The patient may be disposed in a certain position (e.g., a prone position, etc.) on the surgical tableto create greater access to a surgical site for the surgical procedure. Certain positions on the surgical tableand extended time in those positions are more likely to result in pressure injuries to the patient. The use of one or more of the treatment devicesmay be monitored and tracked by the caregivers to update the risk score of the patient during the treatment process of the patient at the medical facility.

2 FIG. 1 FIG. 30 54 12 64 56 50 22 18 18 40 86 18 18 Referring again to, the communication between various information sources, including the local server, the support apparatus, the vital signs monitor, the additional treatment devices, the remote device, and the remote servervia the communication networkis illustrated. The communication networkmay be part of a network of the medical facility(). The network may include a combination of wired connections (e.g., Ethernet) as well as wireless networks, which may include the wireless communication network. The communication networkmay include a variety of electronic devices, which may be configured to communicate over various wired or wireless communication protocols.

2 FIG. 50 56 56 18 56 50 54 22 18 In the illustrated configuration of, the remote devicemay be in wireless communication with each of the treatment devicesand provide for remote access and control of the treatment devices. The communication networkmay include a wireless router through which the remotely accessed treatment devicesand the remote devicemay be in communication with one another, as well as the local serveror the remote servervia the communication network.

18 18 56 50 The communication networkmay be implemented via one or more direct or indirect, non-hierarchical communication protocols, including but not limited to Bluetooth®, Bluetooth® low-energy (BLE), Thread, Ultra-Wideband, Z-wave, ZigBee, etc. Additionally, the communication networkmay correspond to a centralized or hierarchal communication interface where one or more of the treatment devicesor the remote devicecommunicate via the wireless router (e.g., a communication routing controller).

18 86 18 56 12 64 50 22 18 Accordingly, the communication networkmay be implemented via a variety of communication protocols in various combinations, including, but not limited to, global system for mobile communication, general packet radio services, code division multiple access, enhanced data GSM environment, fourth-generation (4G) wireless, fifth-generation (5G) wireless, Wi-Fi, world interoperability for microwave access, WiMAX, local area network, Ethernet, etc. By flexibly implementing the communication network, the various treatment devices, the support apparatus, the vital signs monitor, and the remote devicemay be in communication with one another and the remote serverdirectly via the wireless communication networkor via a cellular data connection.

2 FIG. 20 10 54 10 54 22 20 90 92 94 60 92 90 60 92 20 92 20 90 96 18 94 Referring still to, the control unitof the monitoring systemis illustrated in the local server, though it is contemplated that the monitoring systemmay be partially in the local server, the remote server, or a combination thereof. The control unitincludes a processor, a memory, and other control circuitry. Instructions or routines, including the software associated with the patient profile, are stored in the memoryand executable by the processor. The established patient profilesmay also be stored within the memoryof the control unit. The memorymay be implemented in a variety of volatile and nonvolatile memory formats. The control unitmay include various types of control circuitry, digital or analog, and may include the processor, a microcontroller, an application specific integrated circuit (ASIC), or other circuitry configured to perform various inputs or outputs, control, analysis, and other functions described herein. The control circuitry may also include communication circuitryto permit communication via the communication networkor various protocols for wireless communication in combination with a wired network. The routinesmay include operating instructions to enable the various methods described herein.

20 98 54 98 40 40 98 98 10 98 Additionally or alternatively, the control unitmay be in communication with an asset management system, which may be included in the local server. The asset management systemmay track materials at the medical facilityand monitor when stocks or inventory are low and materials should be ordered. When the caregivers utilize treatment materials and when the medical facilityreceives treatment materials, the information is input to the asset management system, allowing the asset management systemto track the treatment materials utilized in various prevention treatments, including those associated with pressure injuries. The monitoring systemmay also communicate various treatment materials utilized for treating or preventing pressure injuries for monitoring by the asset management system.

5 FIG. 12 14 102 104 106 104 102 12 16 12 18 104 14 102 Referring to, each support apparatusmay include the controllerthat has a processor, a memory, and other control circuitry. Instructions or routinesare stored within the memoryand executable by the processor. The support apparatusmay also include the communication circuitryfor communicating information and data relating to use of the support apparatusvia the communication network. The memorymay be implemented in a variety of volatile and nonvolatile memory formats. The controllermay include various types of control circuitry, digital or analog, and may include the processor, a microcontroller, an ASIC, or other circuitry configured to perform various inputs or outputs and other functions described herein.

12 110 26 110 12 110 112 110 12 The support apparatusmay also include a user interfacethat is included in the user interface assembly. The user interfacemay display a variety of information relating to the support apparatus, the patient, the risk information relating to development of the pressure injury, etc. The user interfacemay include a displayto convey information, as well as receive various inputs from the caregiver or the patient. The user interfacemay be included in any practicable location on the support apparatus, such as on a siderail or a pendant.

12 114 12 114 12 114 114 12 12 10 In various aspects, the support apparatusincludes sensorsfor monitoring information about the support apparatusand the patient thereon. For example, the sensorsmay monitor the position of the support apparatus. In additional non-limiting examples, the sensorsmay sense physiological data, such as heart rate and respiration rate, of the patient through non-contact monitoring. In further non-limiting examples, the sensorsmay monitor the position and movement of the patient on the support apparatus. The information about the patient and the support apparatusmay be utilized by the monitoring systemto determine the likelihood of developing a pressure injury or the likely cause of a pressure injury.

64 116 118 120 122 120 118 120 116 118 Similarly, the vital signs monitormay include a controllerhaving a processor, a memory, and other control circuitry. Instructions or routinesare stored with the memoryand executable by the processor. The memorymay be implemented in a variety of volatile and nonvolatile memory formats. The controllermay include various types of control circuitry, digital or analog, and may include the processor, a microcontroller, an ASIC, or other circuitry configured to perform various inputs or outputs and other functions described herein.

64 68 70 72 64 124 18 64 126 126 The vital signs monitoris in communication with the pulse oximetry sensor, the blood pressure cuff, the electrocardiogram, and any other sensors or devices for obtaining one or more vital signs of the patient. The vital signs monitorincludes communication circuitryfor communicating use data or information as well as vital signs data via the communication network. The vital signs monitoralso includes a user interfacethat is included in the user interface assemblyfor displaying information to the caregiver or patient, receiving an input, or a combination thereof.

56 10 12 64 56 66 130 132 134 136 56 12 18 Other treatment devicesmay include a user interface, a controller, and other similar features associated with the monitoring systemas described relative to the support apparatusand the vital signs monitor. For example, additional treatment devicesincluding the oxygen therapy device, a sequential compression device, a mattressincluding a pneumatic system, and a sub-epidural moisture (SEM) device or scannerin the form of a scanner. Each treatment devicemay communicate directly with the support apparatusor may have communication circuitry to communicate via the communication network.

66 74 130 130 132 134 134 132 136 56 The oxygen therapy deviceprovides oxygen to the patient through the nasal cannula. The sequential compression devicemay generally be configured as a sleeve or mattress pad that includes actuators that sequentially activate to drive fluid or blood in a selected direction (e.g., toward a central cavity of the body). The sequential compression devicemay be used for the treatment of lymphedema, deep vein thrombosis, or other conditions. The mattressmay include the pneumatic systemthat has a plurality of bladders associated with a pump, which controls fluid directed into and out of the bladders. The pneumatic systemmay adjust a pressure of the mattressas well as provide therapies such as alternating pressure therapy or vibrating or percussion therapies. The SEM scannermay provide information relating to the presence of an edema or change in electrical capacitance of tissue, such as sub-epidermal moisture around bony prominences. The illustrated or described treatment devicesare exemplary and are not meant to be limiting.

5 FIG. 56 12 56 12 56 12 12 56 12 54 As illustrated in, the additional treatment devicesare associated with the support apparatus. In such configurations, the treatment devicesare configured to communicate with the support apparatus. Generally, the additional treatment devicesmay be directly coupled with the support apparatus. The support apparatusmay then communicate the data from the additional treatment devicesand the support apparatusto the local server.

56 12 18 12 64 56 56 60 It is also contemplated that the additional treatment devicesmay be separate from the support apparatusand configured to communicate via the communication networkin a similar manner as the support apparatusand the vital signs monitor, as set forth herein. It is also contemplated that certain treatment devicesmay not be configured to communicate use information. Use information from these treatment devicesmay be manually inputted into the patient profileby the caregiver through the application.

6 FIG. 7 FIG. 56 150 86 40 18 56 150 56 12 56 150 86 152 Referring still to, as well as, in certain aspects, some or all of the treatment devicesare configured to communicate with a wireless access transceiver, which is coupled to Ethernetof the medical facility. The communication networkprovides for bidirectional communication between the treatment deviceand the wireless access transceiver. In the example illustration, the treatment deviceis illustrated as the support apparatusbut may be any practicable treatment device. The wireless access transceivercommunicates bidirectionally with Ethernetvia a data link.

12 154 154 40 12 154 10 54 50 52 12 12 40 154 156 86 154 86 154 12 12 154 150 The support apparatusmay be associated with a network interface unit. Multiple network interface unitsmay be provided in various locations within the medical facility. Each support apparatusand each network interface unitis assigned a unique identification (ID) code such as a serial number. Various components of the monitoring system(e.g., the local server, the remote device, the facility connected device, or a combination thereof) may include software (e.g., routines) that operates to associate the ID of the support apparatuswith the network interface unit ID data to locate each support apparatuswithin the medical facility. Each network interface unitincludes a portfor selectively coupling with Ethernet. When the network interface unitis coupled with Ethernet, the network interface unitcommunicates the ID data to the support apparatus, which then wirelessly communicates the ID data for the support apparatusand the network interface unitto the wireless access transceiver.

7 FIG. 7 FIG. 56 40 158 56 12 64 56 Referring still to, some or all of the treatment deviceswithin the medical facilitymay be capable of communicating wirelessly via a wireless communication module. In the illustrated configuration of, which is exemplary and not meant to be limiting, the treatment devicesare illustrated as the support apparatusand the vital signs monitor. It is contemplated that each treatment devicedisclosed herein may be configured to operate in a similar manner to communicate wirelessly, as set forth in further detail herein.

158 12 16 64 124 160 160 162 158 160 162 86 86 54 54 56 The wireless communication modulesgenerally communicate via an SPI link with circuitry of the associated support apparatus(e.g., the communication circuitry) and circuitry of the vital signs monitor(e.g., the communication circuitry) and via a wireless 802.11b link with wireless access points. The wireless access pointsare generally coupled to Ethernet switchesvia 802.3 links. It is contemplated that the wireless communication modulesmay communicate with the wireless access pointsvia any of the wireless protocols disclosed herein. Additionally or alternatively, the Ethernet switchesmay generally communicate with Ethernetvia an 802.3 link. Ethernetis also in communication with the local server, allowing information and data to be communicated between the local serverand the various treatment devices.

1 7 FIGS.- 56 12 64 56 54 56 50 52 22 46 56 56 Referring to, when the treatment devices, including the support apparatus, the vital signs monitor, and the additional treatment devices, are coupled to the local server, each may wirelessly transmit use data, directly or indirectly. The use data or information may include the duration of use, type of use, therapies applied, patient data (e.g., position, pressures, physiological information, movement, etc.), or any other data useful to the caregiver. The data from the treatment devicesmay be routed to different remote devicesand facility connected devicesor to different software programs within the respective device or server. The data may also be communicated to the remote serverto be included or stored in the EMRassociated with the patient. The wireless communication between the various treatment devicesmay be at different frequencies or different times. Accordingly, communication circuitry of the various treatment devicesmay operate independently of one other.

54 26 26 50 52 110 12 126 64 26 It will be understood that the use data, the patient data, or other data received from the local servermay be displayed on the user interface assembly. The user interface assemblyincludes, for example, the remote device, the facility connected device, the user interfaceof the support apparatus, and the user interfaceof the vital signs monitor. This provides a variety of places the caregiver can observe information about the patient, including the risk information. Accordingly, the user interface assemblyallows for continued updates to the caregiver regarding the risk of developing a pressure injury.

8 9 FIGS.and 1 7 FIGS.- 8 FIG. 50 50 52 54 22 58 172 26 26 172 172 60 Referring to, as well as, the application or software operating on the remote devicemay provide for communication between multiple remote devicesassociated with different caregivers, the facility connected deviceor devices, the local server, and the remote servervia the caregiver interaction system. A graphical representation of an application interfacedisplayed on the user interface assemblyis illustrated in. Each user interface of the user interface assemblymay have a similar configuration as the application interfacebased on the application or software operating on the respective device. Alternatively, the configuration of the application interfacemay differ based on the specific configuration of the user interface, while displaying the information and data sought by the caregiver. It is contemplated that each patient profilemay include the risk information, details of the patient, chat messages between caregivers, etc.

172 170 60 60 60 170 170 The application interfaceis configured to display a communication portalfor each caregiver including multiple patient profiles, with each patient profilecorresponding to one patient associated with the caregiver. Each caregiver associated with the patient is granted access to the respective patient profile, which can be accessed through the communication portal. Additionally or alternatively, the communication portalprovides a way for each caregiver associated with the patient to communicate with one another, as well as a way to receive updates about the patients.

9 FIG. 60 172 60 40 60 40 Referring still to, an exemplary patient profileis illustrated on the application interface. The patient profileallows for messaging and sharing information (e.g., a chat feature) relating to the patient between various caregivers throughout the treatment process of the patient at the medical facility. Accordingly, the caregivers can directly message one another through the patient profilethroughout the preoperative phase, the intraoperative phase, the postoperative phase, or any other treatment process at the medical facility. The caregivers can discuss the treatment of the patient, request tasks to be done, and share information about the status of the patient or the treatment.

8 FIG. 10 FIG. 10 FIG. 170 174 172 174 56 172 60 Referring again to, as well as, the communication portalmay indicate when there is a risk alertregarding a certain patient. The caregiver may select the alert icon to view the alert information, as illustrated in. The application interfacemay then provide the information relating to the risk alert. For example, if a patient is deemed at risk of developing a pressure injury through a surgical procedure, use of the medical or treatment device, or another method, the application interfaceprovides a way to communicate the risk information to each caregiver associated with the patient profile.

10 FIG. 10 FIG. 172 172 24 176 178 As best illustrated in, the application interfacecommunicates a variety of risk information and data of the patient to the caregiver. In the exemplary configuration of, the application interfacedisplays the notification, which includes a risk status indicatorthat communicates to the caregiver whether the patient is considered at risk of developing a pressure injury (e.g., the risk status), a risk score indicatordetermined through the methods described in further detail herein and/or the initial risk assessment as described herein, etc.

172 180 172 182 180 20 24 172 Additionally, the application interfacemay display a risk assessmentof the patient, including the factors that contribute to the risk score, the risk status, and the likelihood of the patient developing a pressure injury. Further, the application interfacemay communicate risk areasto the caregivers, thereby allowing the caregiver to monitor areas of the body of the patient that are more likely to develop a pressure injury based on the risk assessment. Each of these may be selectable features that cause the control unitto generate a subsequent or updated notificationupon a selection. Generally, the application interfacecommunicates information to each caregiver associated with the patient to allow the caregivers to provide prevention treatment or measures and monitor the patient for pressure injuries. The risk information and data may be updated throughout the perioperative or treatment process of the patient.

10 FIG. 11 FIG. 2 FIG. 172 184 182 24 24 186 182 182 20 182 184 46 20 182 184 24 Referring still to, as well as, the application interfacemay provide an icon or graphical representationof the risk areasof the patient. For example, the notificationincludes a graphic or icon of a person. The notificationalso includes an identifier, such as an arrow, a shape, a highlighted area, etc., on the icon that corresponds with the risk areas. The identified areasmay be automatically generated by the control unit. Additionally or alternatively, the caregiver may highlight or otherwise indicate various areasthat are determined to be at risk of developing a pressure injury. The graphical representation, as well as other risk information, may also be included in the EMR() of the patient. As the control unitreceives additional information, the risk areas, as well as the graphical representationin the notification, may be updated and communicated to the caregiver.

10 11 FIGS.and 12 FIG. 8 FIG. 24 172 188 180 182 188 188 172 188 182 20 10 Referring still to, as well as, the notificationdisplayed on the application interfacemay present tasks or treatment ordersthat relate to prevention treatment for the patient in response to the risk information (e.g., risk status, risk score, risk assessment, risk areas, etc.). The treatment ordersmay be generated and displayed in response to the selection of an icon for the treatment orderson the application interface(e.g., as illustrated in). The treatment ordersmay be tailored to the specific risk areasor risk factors of the patient and may be generated by the control unit. The risk factors are generally factors utilized by the monitoring systemto determine how and why the patient likely developed the pressure injury.

188 188 182 132 In the treatment orders, the caregiver is provided with a specific listing of tasks for treating the patient to prevent or minimize a potential pressure injury from developing. The treatment ordersmay include, but are not limited to, Q2 turns (e.g., turning the patient at two hour intervals to keep the patient from lying on a risk area), use of an offloading device (e.g., a heel boot, etc.), recommendation for an offloading position (e.g., place the patient on the left side as patient spent a certain amount of time on the right side), order or upgrade a therapeutic surface to a specialty mattress, consult a wound, ostomy, and incontinence nurse (WOCN), apply barrier creams, utilize anti-shear and friction pads (e.g., Mepilex® pads), institute incontinence management, promote microvascularization, etc.

172 188 188 60 188 188 20 24 190 9 FIG. The application interfacemay be advantageous for quickly sharing information between caregivers. For example, one caregiver may view the treatment ordersand may “share” the treatment ordersthrough the chat feature of the patient profile, as illustrated in. Additionally, the caregiver who conducts a task or treatment ordercan mark the treatment orderas completed to communicate to the other caregivers what actions have been completed and what tasks are still incomplete. In this way, the control unitmay update the notificationwith completion identifiers(e.g., checks, strikethrough, etc.) that correspond with the completed tasks.

188 174 50 52 26 46 172 46 188 188 188 48 22 2 FIG. 2 FIG. The treatment ordersand the risk alertmay be provided through the application or software acting on any of the remote devices, the facility connected device, the user interface assembly, or a combination thereof. Additionally, this information may also be communicated to the EMR() associated with the patient and stored therein. Accordingly, when the caregiver accesses the application interfaceor EMR, the caregiver is alerted of the risk status and associated tasks or treatment ordersfor the patient. The treatment ordersmay also include more general tasks for preventing pressure injuries that may not be specific to the patient. The treatment ordersmay be directed by the facility risk protocol() stored in the remote server.

13 FIG. 24 172 194 194 20 194 194 194 10 172 20 24 194 Referring to, the notificationdisplayed on the application interfacemay provide for viewing or updating a discharge report. The caregiver may manually generate or update the discharge report. Additionally or alternatively, the control unitmay automatically generate or update the discharge report, or a portion of the discharge report, to include information and education related to the potential pressure injury and the risk of the patient of developing the pressure injury. The discharge reportmay be automatically updated based on the risk status, the risk score, observations of the caregiver, etc. input into the monitoring system. The application interfacemay include a selectable feature that, when selected, causes the control unitto generate the updated notificationincluding the discharge report.

194 10 194 40 The discharge reportmay include risk factors, information or data on how to identify a pressure injury, information relating to when to notify the caregiver about a potential pressure injury, information on contacting the caregiver for pressure injury related treatment, or any educational or other information useful for the patient or subsequent caregiver. Accordingly, the monitoring systemassists in providing education to the subsequent caregiver or the patient after discharge. The information included in the discharge reportmay be updated or altered based on where the patient is being discharged to (e.g., within the medical facilitycompared to home) and the patient.

14 FIG. 172 196 20 196 196 196 Referring to, the application interfacemay also provide a feedback reportthat is communicated to each caregiver associated with the patient when the patient has developed a pressure injury. Generally, the control unitgenerates the feedback reportas discussed in further detail herein. The feedback reportprovides, for example, information relating to the risk score, a listing of risk factors, details of the pressure injury, potential causes or contributing factors of the pressure injury, identification of the pressure injury, or any other information useful to the caregiver. Additional information that may be useful to the caregivers may also be included in the feedback report, such as, for example, details on the pressure injury, details of the location of the pressure injury, etc.

10 12 56 56 10 10 80 44 10 10 196 10 As previously stated, the risk factors are generally factors utilized by the monitoring systemto determine how and why the patient likely developed the pressure injury. In other words, the risk factors are contributing factors related to the development of the pressure injury. These contributing risk factors include, for example, characteristics of the pressure injury, length of time on the support apparatus, length of treatment, a procedure or diagnosis, treatment devicesutilized, areas the treatment deviceswere utilized, or a combination thereof. The monitoring systemutilizes the risk factors to determine a likely cause of the pressure injury and conveys the likely cause, along with the listing of risk factors, to the caregivers. The likely cause may include specific equipment and the monitoring systemmay associate the equipment with a certain perioperative phase (e.g., the surgical tablein the surgical suite). The monitoring systemmay also include a time or phase of the perioperative environment, which was the likely cause of the pressure injury without specific equipment. In this way, the monitoring systemprovides an explanation in the feedback reportfor a determined cause of the pressure injury and for how the monitoring systemdetermined the likely cause of the pressure injury.

10 196 44 56 196 46 2 FIG. Accordingly, the monitoring systemprovides feedback to each caregiver and each caregiving team regarding the status of the patient in developing a pressure injury. In certain aspects, an operating team for the patient also receives the feedback report, which may be advantageous for alerting the operating team if the pressure injury was likely caused in the surgical suiteor by a specific treatment device. The feedback reportmay also be stored in the EMR() of the patient.

196 172 170 46 196 196 196 56 Accordingly, each caregiver may be alerted of the feedback reportwhen accessing the application interface(including in the communication portal) and the EMRof the patient. The feedback reportassists in monitoring the health of the patient as well as monitoring actions taken by the caregiving team that contributed to the pressure injury. In this way, the feedback reportsmay be utilized to improve the care provided to the patient. The information in the feedback reportmay be updated based on the type of injury, the severity of the injury, timing of the onset of the injury, type of procedure, type of treatment deviceutilized, etc.

196 48 10 196 48 196 48 48 The feedback reportmay also include facility risk protocols. Depending on the information provided to the monitoring system, the feedback reportmay also include whether actions of the caregiving team followed or deviated from the facility risk protocols, which may have affected the development of the pressure injury. The feedback reportwith the facility risk protocolsmay also assist in updating the facility risk protocolsover time.

15 FIG. 1 14 FIGS.- 20 20 20 Referring to, as well as, the control unitmay perform various methods for tracking and monitoring a risk associated with the patient developing a pressure injury, communicating information relating to the factors that contribute to the risk, communicating educational information to the caregiver and the patient, and communicating the development of a pressure injury to the caregiver. The control unitmay operate with a rules-based software, a predictive software, or a combination thereof. Further, the control unitmay also perform methods directed to pressure injuries obtained in the perioperative process, medical device related pressure injuries, or a combination thereof.

15 FIG. 20 10 200 202 200 20 46 46 20 22 18 For example, as illustrated in, the control unitof the monitoring systemmay perform a methodfor monitoring and tracking the risk and/or development of a pressure injury through operating a rules-based software. In stepof the method, the control unitcollects or retrieves data from the EMRof the patient. The information may be scraped from notes within the EMRvia natural language processing. The control unitcommunicates with the remote servervia the communication network.

46 46 Generally, the data or information retrieved from the EMRrelates to patient demographics. For example, information collected from the EMRmay include, but is not limited to, age, history of pressure injuries, procedure or treatment to be performed or that has already been performed, comorbidities such as diabetes, malnutrition, any vascular issue, smoking history, patient weight, patient BMI, nothing by mouth (NPO) status, medications, the risk score obtained at the initial intake, any subsequent risk scores, data from another unit or home care, data from home care equipment, lab data such as hemoglobin, hematocrit, creatine, and other lab data that captures a current hydration status, etc.

204 20 56 40 20 62 80 62 12 114 20 114 12 12 50 52 20 20 12 40 In step, the control unitcollects or retrieves use data or information from the various treatment devicesutilized by or for the patient at the medical facilityin the perioperative environment. For example, the control unitmay retrieve data from preoperative and postoperative devices, such as the medical bedor the surgical table, to obtain information regarding the period of time the patient was positioned on the medical bed. The support apparatusmay include the sensorsthat sense a variety of information and communicate the information to the control unit. The sensorsmay be configured to sense movement of the patient, physiological data of the patient, position of the patient on the support apparatus, position of the support apparatus, etc. Additionally, the use information may be manually inputted into the remote deviceor the facility connected deviceby the caregiver and communicated to the control unit. It is also contemplated that the control unitmay obtain use information from other support apparatuses, including those in the emergency department, a radiology department, and other areas or units of the medical facility.

12 12 20 20 204 70 64 130 20 136 In addition to time positioned on the various support apparatuses, the use information relating to the time the patient is not positioned on the support apparatusesprior to the surgical procedure may also be communicated to the control unit. Additional information retrieved or collected by the control unitin stepmay include the time of using the blood pressure cuffassociated with the vital signs monitoror time of use of the sequential compression device. Additionally or alternatively, the control unitmay be in communication with the SEM scanner, which provides information relating to the presence of edema and chance in the electrical capacitance of tissue, such as sub-epidermal moisture around bony prominences.

204 20 56 44 20 80 80 80 20 80 80 132 44 56 Further, in step, the control unitmay also obtain data from devicesfrom the intraoperative phase within the surgical suiteutilized during the surgical procedure. For example, the control unitmay obtain use information from the surgical tableincluding time on the surgical tableand position of the surgical table. Additional information that may be obtained by the control unitmay include, but is not limited to, the position of the patient on the surgical table, cumulative time spent in each position on the surgical table, use of positioning devices (e.g., arm boards, prophylactic pressure injury prevention dressings, etc.), micro-movements of the patient (e.g., nursing protocols where the nurse or caregiver is moving patient extremities to offload pressure, unintended movements during surgery, or sliding), use of warming devices such as blankets or specialized mattresses, anesthetic medication or gases used, temperature within the surgical suite, other treatment devicesin contact with the patient during the perioperative phases, etc.

44 56 18 56 50 52 20 18 This information from the surgical suitemay be provided directly from the selected treatment devicethrough the communication network. It is also contemplated that use information regarding any of the treatment devicesmay be manually input by the caregiver through the remote deviceor the facility connected device, which may then be communicated to the control unitthrough the communication networkor through any of the wired or wireless protocols disclosed herein.

206 20 202 204 200 20 202 204 92 20 20 80 20 20 20 200 In step, the control unitdetermines the risk status of the patient in response to the data received during stepsandof method. In the rules-based software, the control unitmay compare data received in stepand stepwith various rules or threshold factors stored within the memoryof the control unitand determine if the rule has been satisfied. Any one or more of the inputs may be utilized as a rule by the control unit. The rules-based software may be based on a single rule or threshold factor. For example, when the patient is positioned on the surgical tablefor a period of time greater than a predefined amount of time, the control unitautomatically determines that the patient is at risk for developing a pressure injury. Additionally or alternatively, the rules-based software may use multiple factors or conditions to determine whether the patient is at risk (e.g., if a predefined condition is satisfied or not). For example, if the patient is over a predefined age and a surgical procedure lasts longer than a predefined amount of time, the control unitautomatically determines that the patient is at risk. The rules utilized by the control unitmay be configured within the software by a rules manager and implemented within the method.

208 20 60 172 46 210 20 24 60 172 24 46 24 10 11 FIGS.and In step, the control unitmarks the patient as at risk or not at risk (e.g. the risk status) within the patient profile. This indication appears on at least one of the application interfaceand the EMR. In step, the control unitgenerates the notificationthat is sent to the patient profileand displayed on the application interface. It is also contemplated that the notificationis sent to the EMR. The notificationincludes a variety of information relating to the risk status of the patient, as illustrated in.

24 172 24 184 182 186 172 46 24 24 24 11 FIG. Additionally or alternatively, the notificationmay be a graphical or another alert that prompts the caregiver to view the risk information on the application interface. In certain aspects, as illustrated in, the notificationmay include a graphical schematic or the graphical representationof a human body with the risk areashighlighted or otherwise identified by the identifierto the caregiver. When the caregiver accesses either the application interfaceor the EMR, the notificationis automatically presented to the caregiver. The notificationmay operate as an alert to prompt the caregiver to provide pressure injury risk assessments or care. The notificationmay be utilized as a best practice alert to prompt the caregiver at different times in the treatment process for the patient.

15 FIG. 12 FIG. 212 20 188 188 24 24 188 56 188 172 188 20 Referring still to, in step, the control unitgenerates the treatment ordersthat are communicated to the caregiver. The treatment ordersmay be included in the notification, may be accessible through the notification(e.g., a selectable feature), or may be a separate alert. The treatment ordersgenerally relate to reminders to track pressure injury risk and provide preventative treatment based on the risk status of the patient, the surgical procedure, the treatment devicesutilized with the patient, etc. The treatment ordersmay be displayed on the application interface, as illustrated in. The generated tasks or treatment ordersare generally specific to the patient based on the inputs received and risks determined by the control unit.

188 132 188 212 20 98 40 10 98 The treatment orderstriggered by the risk status of the patient may include, but is not limited to, Q2 turns, use of an offloading device, recommendation for an offloading position, order or upgrade a therapeutic surface to a specialty mattress, consult a WOCN, apply barrier creams, utilize anti-shear and friction pads, institute incontinence management, promote microvascularization, etc. The treatment ordersmay also include treatment materials to be utilized by the caregiver to prevent or treat the pressure injury. In step, the control unitis configured to communicate with the asset management systemto monitor the inventory of treatment materials at the medical facility. As the caregiver utilized various treatment materials, the caregiver may input information to the monitoring systemabout the use and quantity of the treatment materials utilized. The asset management systemmay then update and monitor the inventory or use of the treatment materials.

214 20 194 194 194 56 194 13 FIG. In step, the control unitgenerates or updates the discharge reportfor the patient or the subsequent caregiver. Updating the discharge reportmay be advantageous for having an automatic process to include information and data related to pressure injuries for the patient or the subsequent caregiver. The discharge reportmay include a listing of risk factors specific to the patient, information on how to identify pressure injuries including, for example, timing relative to a surgical procedure or increased risk due to a certain treatment device, and/or when and how to contact the caregiver related to a pressure injury, as illustrated in. Accordingly, the discharge reportmay provide educational information to the patient when the patient is discharged to the subsequent care environment and/or when the patient is discharged home.

10 In examples when the patient is discharged home shortly after the surgical procedure, the protocol for the caregiver may include a follow-up call, visit, or other communication with the patient. The follow-up call or appointment may include questions regarding symptoms of pressure injuries to obtain the information about whether the pressure injury has developed and, if so, details of the pressure injury to be communicated to the monitoring system.

216 20 196 196 218 196 196 46 40 196 14 FIG. In step, if the patient develops a pressure injury, as uncovered by the caregiver or the patient, the control unitautomatically generates the feedback report. The feedback reportmay include details of the pressure injury, details of the surgical procedure that may have contributed to the risk status of the patient, and/or other information relating to the pressure injury that may be beneficial to the caregivers, as illustrated in. In step, the feedback reportis sent to the caregivers, including, for example, one or more of the surgical team, a primary care physician, a surgeon, an intensive care unit, a medical/surgical unit, and an offsite care facility. The feedback reportmay also be communicated to the EMRof the patient. Accordingly, if the patient develops pressure injury due to the surgical procedure conducted at the medical facility, each caregiver associated with the patient is informed of the pressure injury and potential contributing factors. The feedback reportmay be advantageous for alerting caregivers of additional prevention treatment options, as well as training to provide better care for the patient.

16 FIG. 1 15 FIGS.- 15 FIG. 230 20 232 20 46 202 200 234 204 200 20 56 56 12 62 80 64 130 136 56 56 Referring to, as well as, in method, the control unitutilizes predictive software for predicting the likelihood of developing the pressure injury. The likelihood of developing the pressure injury may be quantified as a number within a range (e.g., out of 100), a percentage, a high/medium/low indication, or any other practicable scale. In step, the control unitcollects data from the EMRof the patient, which is conducted in a similar manner as stepfrom methodas described herein. In step, similar to stepof methodin, the control unitobtains use information from the various treatment devicesutilized by the patient. The treatment devicesmay include one or more of the support apparatus(e.g., the medical bed, the surgical table, etc.), the vital signs monitor, the sequential compression device, the SEM scanner, as well as other treatment devicesdescribed herein or any treatment devicesutilized to treat or care for the patient.

236 20 20 230 20 172 56 58 40 In step, the control unitcalculates the risk score. When calculating the risk score, the control unitcompares weighted factors or inputs. The factors or inputs include the information retrieved in the previous steps of method. The weight assigned to each factor or input may be assigned by a rules manager of the software program. The control unitmay use a predictive algorithm such as, for example, logistic regression, random forest algorithm, or other machine learning models. Table 1, included below, includes exemplary factors or inputs received by manual input through the application interface, received directly from at least one of the treatment devices, the caregiver interaction system, other systems of the medical facility, or a combination thereof, which are weighted and added together to calculate the risk score.

TABLE 1 Data Inputs Pre-op/Post-op Intra-op EMR Data Device Data Device Data Patient age Time in bed or on a Time on a surgical History of pressure stretcher before and table injuries after surgery Patient positions on a Patient procedure Times out of bed in a surgical table Comorbidities, such as preoperative Cumulative time in diabetes, de-nutrition, environment each position vascular issues Measured micro- Use of positioning Smoking history climate devices Patient weight, BMI Medication Micro-movements of NPO status administered during patient Patient medication pre-op/post-op Use of warming PI risk score from a Any complications devices perioperative related to post-op Anesthetic environment (confusion, pain, etc.) medications and gases Lab data (Hbg/Hct, Medical device albumin, creatine, related pressure injury hydration-related, assessment etc.) Data about transfer from another unit or from home

20 236 20 20 80 20 The control unitmay utilize the data received from the various inputs and calculate the risk score corresponding with the likelihood of developing the pressure injury. Additionally or alternatively, in step, the control unitmay combine the predictive algorithm with the rules-based algorithm as described herein. In such examples, the predictive algorithm weighing the various factors is utilized until a specific condition is recognized by the control unit. For example, the condition may be that a predetermined amount of time on the surgical tablehas been exceeded or that the patient uses vasopressors. Once the condition is recognized by the control unit, the rules-based algorithm may override the predictive algorithm.

238 20 20 20 In step, the control unitdetermines whether the patient is at risk or not at risk of developing a pressure injury based on the calculated risk score. The control unitmay store a predefined value that is compared to the calculated risk score. If the risk score is above the predefined value, the control unitmarks the patient as at risk and indicates the severity of the risk. Additionally, if a certain condition has been met to override the predictive algorithm, the condition may be noted with the risk score.

10 200 240 20 24 242 20 188 244 20 194 246 20 196 248 196 242 248 212 218 200 After calculating the risk score, the monitoring systemcontinues in a similar manner as method. In step, the control unitgenerates the notification. In step, the control unitgenerates treatment ordersfor the caregiver based on the risk score. In step, the control unitgenerates the discharge report. In step, the control unitgenerates the feedback report, and in stepthe feedback reportis sent to the caregivers associated with the patient. It is contemplated that steps-are performed in a substantially similar manner as the steps-of methoddescribed herein.

15 16 FIGS.and 200 230 80 56 20 20 40 Referring to, the methods,generally follow a process for monitoring and tracking general pressure injury risk in the perioperative environment. The risk is associated with an intraoperative time on the surgical table, as well as certain positions or positioning devices (e.g., treatment devices) utilized on the patient, and other time in the perioperative environment. The control unitmay also determine the risk status or the risk score associated with the patient based on the use of a certain treatment device. In this way, the control unitmay also determine a medical device related pressure injury risk. In such circumstances, the patient may or may not be part of the perioperative environment, but may be at the medical facilityfor other treatment or care.

17 FIG. 1 16 FIGS.- 20 260 262 20 46 20 56 40 56 46 202 200 232 230 Referring to, as well as, the control unitmay be configured to perform a methodof monitoring and tracking risk and/or development related to medical device related pressure injuries. In step, the control unitcollects data from the EMRusing a natural language process. The control unitcollects information relating to patient demographics, as well as information on treatment devicesused during a surgical procedure or otherwise used during treatment at the medical facility. For example, the data or information may include patient age, history of pressure injuries, a procedure surgery or treatment, a medical device (e.g., the treatment device) associated with the procedure, surgery, or treatment, comorbidities such as diabetes, patient weight, a perioperative pressure injury risk assessment such as the Braden score, the Norton score, the Waterlow score, or a combination thereof, the pressure injury risk assessment including the Scott Triggers, information transferred from another unit, whether the patient is coming from home, etc. The data collected and how the data is collected from the EMRmay be similar to the process described in stepof methodand stepof method.

264 56 172 10 56 20 12 64 66 130 132 136 In step, use information relating to various treatment devicesis input through the application interfaceor otherwise input by the caregiver into the monitoring system. The manually input use information may relate to treatment devicesthat may not include a controller in communication with the control unit. The use information may relate to the support apparatus, the vital signs monitor, the oxygen therapy device, the sequential compression device, the mattress, the SEM scanner, etc.

56 74 66 134 132 132 Additionally or alternatively, the use information may relate to any treatment devices, including, but not limited to the nasal cannulaused in association with the oxygen therapy device, oxygen tubing for ears, a Foley catheter, a cast, a splint, a cervical collar, a CPAP mask, a BiPAP mask, an endotracheal tube, a feeding tube, a halo brace, and a tracheostomy neck plate, other braces, positioning devices, therapy provided to the pneumatic systemof the mattress, the pressure within the mattress, offloading devices, anti-shear and friction pads, etc.

266 20 56 20 18 56 204 200 234 230 In step, the control unitcollects data from the treatment devicesin communication with the control unitvia the communication network. The treatment devicesmay communicate data or the information in a similar manner as stepof methodand stepof methodaccording to any wireless or wired protocol as described herein.

268 20 262 266 260 20 260 20 20 In step, the control unitdetermines the risk status of the patient for developing a medical device related pressure injury utilizing the data received in steps-of method. The control unitmay utilize rules-based algorithms in method. The control unitmay have a single rule that determines whether the patient is at risk. For example, if the patient has worn a neck brace for a period of time exceeding a predefined period of time, the patient is automatically marked as at risk. Additionally or alternatively, the control unitmay utilize multiple factors to determine whether the patient is at risk. For example, if the patient is over a certain age and a neck brace has been worn for a period of time greater than a predefined amount of time, then the patient is automatically marked as at risk.

270 20 60 272 20 262 266 48 182 48 22 272 20 22 18 48 48 24 188 20 In step, the control unitmarks the patient as at risk or not at risk in the patient profile. In step, the control unitcross-references the risk status and the data received in steps-to the facility risk protocolassociated with the initial risk score, the risk status, the risk area, the pressure injury, or a combination thereof. The facility risk protocolmay be stored within the remote server. Accordingly, in step, the control unitmay communicate with the remote servervia the communication networkto cross-reference the risk with the facility risk protocol. The facility risk protocolmay guide the information to be included in the notificationand the treatment ordersto be generated by the control unit.

274 20 24 172 24 276 20 188 24 188 182 188 24 46 10 11 FIGS.and 12 FIG. In step, the control unitgenerates the notificationthat is communicated to the caregiver via the application interface. The notificationgenerally indicates to the caregiver that the patient is at risk (e.g., the risk status), as well as includes contributing factors to the risk status, as illustrated in. In step, the control unitgenerates the treatment orderrelated to prevention treatment for the potential medical device related pressure injury. The notificationmay include reminders, tasks, or treatment ordersassociated with the risk status or at risk areasof the patient (e.g., areas with greater or increased risk of a pressure injury), as illustrated in. The treatment ordersmay include, for example, reminders to tape tubing, reminders to replace foam protectors, reminders to check for medical device related pressure injuries, etc. These notificationsmay also appear in the EMR.

188 188 20 56 24 48 22 Additionally or alternatively, the treatment ordersmay include the size and type of materials to use for the prevention treatment (e.g., the treatment order), as well as when to replace the materials. The control unitmay utilize information such as the location of the treatment device, the size of the patient, and the risk status of developing a medical device related pressure injury to provide treatment guidance to the caregiver. It is also contemplated that the notificationincludes the facility risk protocolsretrieved from the remote serverto guide or prompt the treatment provided by the caregiver.

276 20 98 20 98 22 54 48 22 98 40 Additionally, in step, if the control unitis in communication with the asset management system, the control unitmay send an alert or notification to the asset management systemto automatically order or prompt the ordering of materials that are low in stock or that a patient may need changed or utilized periodically. Whether the materials are low in stock may be stored in the remote serveror the local server. The materials the patient may need for various treatments and the frequency of changing the materials may be stored within the facility risk protocolsin the remote server. The treatment materials utilized by the caregiver may be communicated to the asset management systemto track the inventory of the treatment materials at the medical facility.

18 FIG. 1 17 FIGS.- 20 20 290 292 20 46 Referring to, as well as, the control unitmay utilize a predictive algorithm for determining the likelihood of the patient to develop a medical device related pressure injury. The control unitmay perform methodto monitor and track the risk and/or development of the medical device related pressure injury. In step, the control unitcollects data from the EMRwith natural language processes, as described herein. The data or information may include patient age, history of pressure injuries, a procedure surgery or treatment, a medical device associated with the procedure, surgery, or treatment, comorbidities such as diabetes, patient weight, a perioperative pressure injury risk assessment such as the Braden score, the Norton score, the Waterlow score, or combination thereof, the pressure injury risk assessment including the Scott Triggers, information transferred from another unit, whether the patient is coming from home, etc.

294 56 20 68 70 74 In step, the caregiver inputs information regarding the use of certain treatment devicesthat may or may not be in direct communication with the control unit. For example, information relating to the use of positioning devices or other device attachments in an intraoperative setting, the pulse oximetry sensor, the blood pressure cuffs, the nasal cannula, braces, off-loading devices, etc.

296 20 56 20 18 266 260 56 12 12 80 80 80 In step, the control unitcollects use data from the treatment devicesthat are directly in communication with the control unitvia the communication network, according to any of the wired or wireless communication protocols described herein. The data is collected in a similar manner to stepof methodset forth herein. The use information of the treatment devicesmay include the position of the patient on the support apparatus, time spent on the support apparatus, a specific surgical table, a specific position on the surgical table, positioning devices associated with the surgical table, etc.

298 20 292 296 290 20 20 In step, the control unitmay calculate the risk score of the patient utilizing the data received in steps-of method. The control unitmay store various weights associated with each factor or input assigned by a rules manager. The control unitweighs the factors and determines the risk score of the patient for developing a medical device related pressure injury. Exemplary factors considered to calculate the risk score are set forth in Table 2 below.

TABLE 2 Data Inputs Intra-op Additional EMR Data Device Data Device Data Patient age Time on a surgical Position of the patient History of pressure table on bed injuries Patient positions on a Continuous use of Patient procedure or surgical table monitors, including surgery Cumulative time in blood pressure cuff, Comorbidities, such as each position pulse oximeter, etc. diabetes, de-nutrition, Use of positioning Specific operating vascular issues devices room table Smoking history Micro-movements of Patient weight, BMI patient NPO status Use of warming Patient medication devices PPI risk score from the Anesthetic perioperative medications and gases environment Medical device related Lab data (Hbg/Hct, pressure injury albumin, creatine, assessment hydration-related, Data from a surgical etc.) table on which device Data about transfer attachments were from another unit or used from home Use of medical devices (e.g., feeding tube, nasal oxygen tube)

20 298 20 20 80 56 20 The control unitmay utilize the data received from the various inputs and calculate the risk score corresponding with the likelihood of developing the pressure injury. Additionally or alternatively, in step, the control unitmay combine the predictive algorithm with the rules-based algorithm as previously described herein. In such examples, the predictive algorithm weighing the various factors is utilized until a specific condition is recognized by the control unit. For example, the condition may be that a predetermined amount of time on the surgical tableor utilizing a certain treatment devicehas exceeded a predefined period of time. Once the condition is recognized by the control unit, the rules-based algorithm may override the predictive algorithm.

300 20 20 20 In step, the control unitdetermines whether the patient is at risk or not at risk of developing a medical device related pressure injury based on the calculated risk score. The control unitmay store a predefined value that is compared to the calculated risk score. If the risk score is above the predefined value, the control unitmarks the patient as at risk and indicates the severity of the risk. Additionally, if a certain condition has been met to override the predictive algorithm, the condition may be noted with the risk score.

302 20 48 22 304 20 24 24 306 20 188 20 98 276 260 10 11 FIGS.and In step, the control unitcross-references the risk score, risk factors, at risk areas, etc. with the facility risk protocolstored within the remote server. In step, the control unitgenerates the notificationthat is communicated to the caregiver. The notificationmay include information relating to the risk score, the risk factors, as illustrated in. In step, the control unitgenerates the treatment ordersproviding guidance on prevention treatment and associated materials to use for the prevention treatment, and the control unitmay update the asset management system, similar to stepof method.

200 230 260 290 200 230 260 290 200 230 260 290 20 It is contemplated that the steps of methods,,, andmay occur simultaneously or independently of one another. Additionally, the steps of the associated methods,,,may be performed in any order, simultaneously, repeated, or omitted without departing from the teachings herein. Further, it is contemplated that each of the methods,,,may not be separately applied methods, but various steps from each method may be conducted by the control unitin any given order.

40 40 10 60 40 10 10 Use of the present system may provide for a variety of advantages. For example, the caregivers associated with the patient throughout the medical facilitymay be in direct communication with one another, as well as caregivers at other medical facilities. Additionally, the history of the patient relating to incurring pressure injuries may be tracked through each stage of the treatment process and through each shift of caregivers in various units and departments. Also, any pressure injury obtained by the patient is communicated back to the caregivers. Further, the monitoring systemprovides continuity of communication of ongoing pressure injury risk that follows the patient. The patient profilemay persist indefinitely to provide accurate treatment and care to the patient during each visit to any medical facilityconnected to through the monitoring system. Moreover, the monitoring systemprovides continued communication and assessment of the patient.

10 194 10 10 24 188 10 10 196 196 10 10 10 Additionally, the monitoring systemprovides risk information and education to the patient or subsequent caregiver upon discharge (e.g., the discharge report). Also, the monitoring systemdetermines the risk status and/or calculates the risk score of the patient. Further, the monitoring systemgenerates notificationsto alert caregivers and provide treatment orders, tasks, or guidance on preventative materials to be used by the caregiver. Moreover, the monitoring systemmay improve the care provided to the patient. Additionally, the monitoring systemprovides the feedback reportto the caregivers associated with the patient if a pressure injury develops. The feedback reportmay include the listing of risk factors that sets forth the factors that the monitoring systemutilized in determining the likely cause of the pressure injury. Also, the monitoring systemmay be used for the perioperative environment, may be used to track medical device related injuries, or a combination thereof. The monitoring systemprovides an interconnected communication system between each caregiver associated with the patient to improve the care provided to the patient. Additional benefits and advantages may be realized and/or achieved.

The device and system disclosed herein are further summarized in the following paragraphs and are further characterized by combinations of any and all various aspects described therein.

According to another aspect, a monitoring system for tracking pressure related injury risk includes a support apparatus with a controller and communication circuitry configured to communicate via a communication network. A control unit is configured to communicate with at least one of a remote server and the support apparatus via the communication network. The control unit is configured to determine at least one of a risk status and a risk score for developing a pressure injury in response to communication from the at least one of the remote server and the support apparatus, determine at least one contributing risk factor for developing the pressure injury, and generate a notification configured to be communicated to a user interface assembly.

According to another aspect, a control unit is configured to communicate a notification to a remote device. The notification includes a report that has at least one of a risk score, a risk status, and at least one contributing risk factor related to at least one of the risk score and the risk status.

According to another aspect, a report is a discharge report including at least one of at least one contributing risk factor and information on contacting a caregiver for at least one of pressure injury related prevention and treatment.

According to another aspect, a vital signs monitor is communicatively coupled with a control unit. The vital signs monitor is configured to communicate use information to the control unit. The use information includes time of use of the vital signs monitor.

According to another aspect, a support apparatus includes a surgical table.

According to another aspect, a notification includes a treatment order including prevention treatment based on at least one of a risk status and a risk score.

According to another aspect, a control unit communicates with a user interface assembly to receive use information relating to a treatment device.

According to another aspect, a treatment device is in communication with a user interface assembly. The user interface assembly is configured to receive an input including use information about the treatment device that is configured to be communicated to a control unit. The treatment device includes at least one of a vital signs monitor, a neck brace, a sequential compression device, oxygen tubing for ears, nasal oxygen tubing, a Foley catheter, a cast, a splint, a cervical collar, a continuous positive airway pressure mask, a bilevel positive airway pressure mask, an endotracheal tube, a feeding tube, a halo brace, and a tracheostomy neck plate.

According to another aspect, a control unit is configured to communicate with a remote server to receive facility risk protocols relating to at least one of a pressure injury and a risk score. The notification generated by the control unit includes at least one of the facility risk protocols and a prompt for treatment based on the facility risk protocols.

According to another aspect, a notification includes a treatment order including treatment materials. A control unit is configured to communicate the treatment materials utilized for the treatment order to an asset management system to monitor an inventory of the treatment materials.

According to another aspect, a control unit communicates with a remote server to receive treatment materials associated with a pressure injury. A notification generated by the control unit includes the treatment materials.

According to another aspect, a method of tracking pressure injuries includes collecting data from an electronic medical record of a patient, collecting data from a support apparatus relating to use of the support apparatus, calculating a risk score of developing a pressure injury in response to the data received from at least one of the electronic medical record and the support apparatus, generating a notification including at least one of the risk score, a listing of risk factors, and areas of increased risk, and generating treatment orders based on at least one of the risk score, the listing of risk factors, and the areas of increased risk.

According to another aspect, a method includes generating a feedback report including at least one of details of pressure injury and contributing factors and sending the feedback report to a remote device.

According to another aspect, a method of monitoring medical device related pressure injuries includes collecting first data from an electronic medical record, collecting second data from at least one of a treatment device, a support apparatus, and a user interface, calculating a risk score of developing a medical device related pressure injury with the first data and the second data, cross-referencing a protocol relating to the medical device related pressure injury, and generating a notification if the risk score indicates a patient is at risk for developing the medical device related pressure injury.

According to another aspect, a step of calculating a risk score includes at least one of identifying if a predefined condition is satisfied and comparing multiple predefined conditions.

According to another aspect, a method includes inputting use information relating to the treatment device utilized by a patient into the user interface.

According to another aspect, a method includes generating a task corresponding to at least one of prevention treatment for the medical device related pressure injury and materials to be used for the prevention treatment.

According to another aspect, a monitoring system for tracking pressure related injury risk includes a support apparatus having a controller. The controller is configured to communicate data relating to the support apparatus. Communication circuitry is operably coupled to the support apparatus. The communication circuitry is configured to communicate the data via a communication network. A control unit is configured to communicate with the support apparatus and a user interface assembly via the communication network. The control unit is configured to determine at least one of a risk status and a risk score for developing a pressure injury, determine an area of increased risk for developing the pressure injury, and generate a notification including a graphical representation of a person that is displayed via the user interface assembly.

According to another aspect, a notification includes an identifier on a graphical representation corresponding to an area of increased risk.

According to another aspect, an identifier includes a highlighted area on a graphical representation.

According to another aspect, a control unit is configured to communicate a notification to a remote server via a communication network for storage in an electronic medical record.

According to another aspect, a control unit is configured to generate an updated notification in response to communication from at least one of a support apparatus and a user interface assembly.

According to another aspect, a control unit is configured to determine whether a patient is at risk for developing a pressure injury based on a risk score determined utilizing a predictive algorithm to weigh factors related to a patient and use of a support apparatus.

According to another aspect, a control unit is configured to determine whether a patient is at risk for developing a pressure injury based on satisfying a threshold factor utilizing a rules-based algorithm.

According to another aspect, a monitoring system for tracking pressure related injury risk includes a treatment device with a controller. The controller is configured to communicate data relating to the treatment device. Communication circuitry is operably coupled to the treatment device. The communication circuitry is configured to communicate the data via a communication network. A control unit that communicates with at least one of the treatment device and a user interface assembly via the communication network. The control unit is configured to determine at least one of a risk status and a risk score for developing a pressure injury and generate a first notification configured to be communicated to the user interface assembly. The first notification includes a selectable feature. The selectable feature corresponds to at least one of a risk status indicator, a risk score indicator, a risk assessment, a risk area, and a prevention treatment order. The control unit is configured to generate a second notification in response to a selection of at least one of the selectable features. The control unit is configured to communicate the second notification to the user interface assembly.

According to another aspect, a second notification includes an icon of a person and an identifier on the icon corresponding to a risk area.

According to another aspect, an identifier is a highlighted area on an icon.

According to another aspect, a prevention treatment order includes a listing of tasks. A control unit is configured to update a second notification with completion identifiers corresponding to completed tasks.

According to another aspect, a second notification includes selectable features corresponding to a discharge report and a feedback report.

According to another aspect, a control unit is configured to generate a third notification including a discharge report including educational information related to pressure injury treatment.

According to another aspect, a control unit is configured to generate a third notification including a feedback report configured to be communicated to a caregiver. The control unit is configured to determine information related to a cause of a pressure injury and include the information in the feedback report.

According to another aspect, a control unit is configured to generate a third notification including at least one of a discharge report and a feedback report in response to a selection of a selectable feature of a second notification. The control unit is configured to communicate the third notification to a user interface assembly.

According to another aspect, a control unit is configured to communicate at least one of a first notification and a second notification to a patient profile.

A means for monitoring pressure injury risk comprising a means for supporting a patient having a controller. The controller is configured to communicate data relating to the means for supporting the patient. A means for communicating is operably coupled with the means for supporting the patient. The means for communicating is configured to communicate via a communication interface. A means for controlling communicates with at least one of a means of storing and the means for supporting the patient. The means for controlling is configured to calculate at least one of a risk status and a risk score for developing a pressure injury in response to communication from at least one of the means for storing and the means for supporting the patient and generate a notification to be communicated by a user interface assembly.

Related applications, for example those listed herein, are fully incorporated by reference. Descriptions within the related applications are intended to contribute to the description of the information disclosed herein as may be relied upon by a person of ordinary skill in the art. Any changes between any of the related applications and the present disclosure are not intended to limit the description of the information disclosed herein, including the claims. Accordingly, the present application includes the description of the information disclosed herein as well as the description of the information in any or all of the related applications.

It will be understood by one having ordinary skill in the art that construction of the described disclosure and other components is not limited to any specific material. Other exemplary embodiments of the disclosure disclosed herein may be formed from a wide variety of materials, unless described otherwise herein.

For purposes of this disclosure, the term “coupled” (in all of its forms, couple, coupling, coupled, etc.) generally means the joining of two components (electrical or mechanical) directly or indirectly to one another. Such joining may be stationary in nature or movable in nature. Such joining may be achieved with the two components (electrical or mechanical) and any additional intermediate members being integrally formed as a single unitary body with one another or with the two components. Such joining may be permanent in nature or may be removable or releasable in nature unless otherwise stated.

It is also important to note that the construction and arrangement of the elements of the disclosure, as shown in the exemplary embodiments, is illustrative only. Although only a few embodiments of the present innovations have been described in detail in this disclosure, those skilled in the art who review this disclosure will readily appreciate that many modifications are possible (e.g., variations in sizes, dimensions, structures, shapes, and proportions of the various elements, values of parameters, mounting arrangements, use of materials, colors, orientations, etc.) without materially departing from the novel teachings and advantages of the subject matter recited. For example, elements shown as integrally formed may be constructed of multiple parts or elements shown as multiple parts may be integrally formed, the operation of the interfaces may be reversed or otherwise varied, the length or width of the structures and/or members or connector or other elements of the system may be varied, the nature or number of adjustment positions provided between the elements may be varied. It should be noted that the elements and/or assemblies of the system may be constructed from any of a wide variety of materials that provide sufficient strength or durability, in any of a wide variety of colors, textures, and combinations. Accordingly, all such modifications are intended to be included within the scope of the present innovations. Other substitutions, modifications, changes, and omissions may be made in the design, operating conditions, and arrangement of the desired and other exemplary embodiments without departing from the spirit of the present innovations.

It will be understood that any described processes or steps within described processes may be combined with other disclosed processes or steps to form structures within the scope of the present disclosure. The exemplary structures and processes disclosed herein are for illustrative purposes and are not to be construed as limiting.